National Institute for Occupational Safety and Health

Response to “Interim SC&A Review of the 

SEC Petition Evaluation Report 

for Petition SEC-00256: Pinellas Plant”

Madeline Cook

NIOSH Pinellas Plant Site Lead

Advisory Board on Radiation and Worker Health

Pinellas Plant Work Group Meeting

November 20, 2023
Overview

 Introduction

 NIOSH Responses to 13 SC&A Observations

 NIOSH Conclusion

11/20/2023 2
Introduction 
Evaluation Report (ER) Timeline

 October 13, 2021 – NIOSH published Pinellas Plant Special 

Exposure Cohort (SEC) Petition Evaluation Report (SEC-00256 

ER) [NIOSH 2021a]

 December 8, 2021 – ABRWH tasked SC&A with review of the 

SEC-00256 ER [NIOSH 2021b]

 June 16, 2023 – NIOSH received Interim SC&A Review of the 

SEC Petition Evaluation Report for Petition SEC-00256: Pinellas 

Plant [SC&A 2023]

11/20/2023 4
SC&A Interim Review Executive Summary

 New issues raised by the petitioners may impact SEC. 

 SC&A has not yet reviewed documents found in recent data 

captures. 

However, SC&A is releasing interim review.

 Review had no findings and 13 observations.

11/20/2023 5
SC&A 13 Observations

 Observations 1 – 5 and 11 – 13 based on review of the 

SEC-00256 ER [NIOSH 2021a]

 Observations 6 – 10 based on review of the 1990 Tiger Team Report 

[DOE 1990]

11/20/2023 6
SC&A Observation Issues (1 of 2)

 Four Observations required no response (1, 6, 11, 12)

 Six core issues were the basis for remaining Observations (2-5, 7-10,

13)

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SC&A Observation Core Issues (2 of 2)

11/20/2023 8

Issue Raised by SC&A Observation

Bioassay data completeness relating to: (1) the ability to do a coexposure study and (2) use in assessing SMT exposure 

2, 5, 7, and 9

Reference OTIB-0066 in Occupational Internal Dose TBD 3

Review of monitoring frequency for NOCTS claimants suggests 

bioassay data for 1988-1990 is missing

4

Contamination controls not always followed 8

Tiger Team found management focused more on production than 

adherence to radiological controls

10

Doses are not accounted for given lack of records (4) and bioassay 

compliance (2, 5, 7, and 9)

13
NIOSH Response to SC&A Observation 1

Neutron generator production was fairly steady
Observation 1: SC&A Key Points

“SC&A’s review of neutron generator production from 1974 through 1993 

showed that it was fairly steady, with a peak in the early 1980s and a few 

notable dips in the late 1970s into 1980.”

11/20/2023 10
Observation 1: NIOSH Response

NIOSH concurs with this Observation.

11/20/2023 11
NIOSH Response to SC&A Observation 2

Potential for tritium contamination is adequately addressed 
Observation 2: SC&A Key Points

“...stable metal tritide exposures would only be applied if the energy employee 

were also monitored via urinalysis. However, given the deficiencies noted by 

the Tiger Team ...relying on bioassay completeness to establish exposure 

potential is likely inappropriate.”

11/20/2023 13
Observation 2: NIOSH Response

NIOSH will update Pinellas Plant – Occupational Internal Dose, ORAUT-TKBS0029-5 [ORAUT 2016] to include the guidance: 

“When periods are identified during which an individual claimant should

have been monitored but was not, internal dose from insoluble tritium

(based on the methodology in section 5.8.1.2) will be included in addition 

to soluble tritium dose.”

11/20/2023 14
NIOSH Response to SC&A Observation 3

The ER does not reference recent special tritium compound document
Observation 3: SC&A Key Points

“...NIOSH should commit to reference and discuss guidance from OTIB-0066 in 

the next revision of the occupational internal dose TBD and evaluate whether it 

has any consequential effect on the SEC evaluation report conclusions.”

“...sitewide air monitoring data or contamination survey data should be 

preferentially used over other modeling in dose reconstructions for stable metal 

tritides whenever available.”

11/20/2023 16
Observation 3: NIOSH Response

 OTIB-0066 [ORAUT 2020] provides guidance on using urine bioassay to 

calculate best estimates of the annual organ doses for intakes of tritium in a 

metal matrix. This does not affect SEC ER conclusions.

 The Pinellas method for assessing dose from stable metal tritides uses 

sitewide contamination surveys. It does not rely on urine bioassay. This 

received the concurrence of both the ABRWH and SC&A at the August 2016 

Board meeting [NIOSH 2016b, PDF p. 83]. 

 NIOSH will revise TBD Pinellas Plant – Occupational Internal Dose [ORAUT 

2016] to include a reference to OTIB-0066 [ORAUT 2020].

11/20/2023 17
NIOSH Response to SC&A Observation 4

Lack of bioassay records for 1988–1990
Observation 4: SC&A Key Points

“Despite between 129 and 201 employees reportedly monitored by bioassays 

from 1988 to 1990, NIOSH only has monitoring records for 3–10 claimants per 

year. According to the 1990 DOE Tiger Team report, approximately 1,750 people 

were employed in 1989, suggesting that monitoring records are missing.” 

11/20/2023 19
Observation 4: NIOSH Response (1 of 1)

 Information cited by SC&A was from the ER [NIOSH 2021a] and based on 

internal monitoring data compiled prior to dose reconstruction. 

 A more complete data set is available and used for dose reconstruction. 

 NIOSH has updated the 1988-1990 records information with all bioassay 

data used in each dose reconstruction as well as data received since dose 

reconstruction was performed. (see next slide)

11/20/2023 20
Observation 4: NIOSH Response (2 of 2)

 The monitoring frequency for Pinellas claimants is consistent with that for 

total site personnel.

Table 1. Tritium bioassay data for Pinellas employees, 1988 to 1990.

Year

Total Site 

Personnela

Employees 

(#) 

Monitored 

by Bioassayb

Employees 

(%) 

Monitored by 

Bioassay

Pinellas 

Claimants 

in NOCTSc

Pinellas Claimants 

(#)

Monitored by 

Bioassayd

Pinellas 

Claimants (%) 

Monitored by 

Bioassayd

1988 1720 129 7.5% 310 22 7.1%

1989 1700 201 11.8% 299 35 11.7%

1990 1650 177 10.7% 288 23 8.0%

a Sources: 1988 [GE 1989], 1989 [GE 1990], and 1990 [DOE 1991]

b [Weaver 1992, PDF p. 12]

c As of the SEC-00256 ER [NIOSH 2021a] (through NOCTS Claim #53368)

d Data derived from [Tritium Bioassay Results 1988], [Bioassays and Recounts 1989], [Personnel Bioassay Results 1990]. 

NOCTS update [ORAUT 2023].

11/20/2023 21
NIOSH Response to SC&A Observation 5

Bioassay schedule noncompliance by the plant
Observation 5: SC&A Key Points

“...NIOSH should demonstrate that an appropriate co-exposure model can be 

constructed to address apparent incompleteness in the tritium bioassay 

program.” 

“... Bounding co-exposure values would certainly appear warranted during this 

latter period (1991–1997).” 

11/20/2023 23
Observation 5: NIOSH Response

 NIOSH does not believe demonstrating of a co-exposure model is needed. 

 The Tiger Team's report was a basis for the SEC-00256 ER. [NIOSH 2021a] 

 SEC-00256 ER evaluated and affirmed NIOSH's ability to accomplish dose 

reconstruction even with non-compliance issues (see next slide).

11/20/2023 24
Observation 5: ER Dose Reconstruction 

Evaluation Summary (1 of 3)

 Improved bioassay compliance in response to the Tiger Team findings did 

not result in increased measured doses, suggesting no large exposures went 

unmonitored. 

 NIOSH reviewed NOCTS claims and confirmed that Pinellas monitored 

workers expected to have potential for internal tritium exposure.

11/20/2023 25
Observation 5: ER Dose Reconstruction 

Evaluation Summary (2 of 3)

 All interviewees stated they did not know of a non-compliance issue and 

offered a range of possible reasons. 

– Leave, not removing workers from the bioassay list after reassignment, 

placing workers who entered production areas on a non-routine basis on 

the routine bioassay schedule.

– Implies that non-compliance was not a systemic problem or widespread 

among workers.

11/20/2023 26
Observation 5: ER Dose Reconstruction 

Evaluation Summary (3 of 3)

 Tiger Team found workers with higher exposure potential were more 

compliant with the sampling program than those with less potential. Any 

unmonitored approach based on monitored workers would be biased high.

 NIOSH currently applies the 95th percentile whole body dose (100 mrem) to 

unmonitored workers as a claimant-favorable approach. This received the 

concurrence of both the ABRWH and SC&A at the February 2016 Work 

Group meeting [NIOSH 2016a, PDF p. 24].

NOTE: NIOSH will update Pinellas Plant – Occupational Internal Dose, ORAUTTKBS-0029-5, to explain the approaches for determining internal tritium dose 

when needed for unmonitored personnel.

11/20/2023 27
NIOSH Response to SC&A Observation 6

Radiological protection program commended by Tiger Team
Observation 6: SC&A Key Points 

“On a positive note, commending the radiological protection program, section 

4.4.11.1 (p. 4-90) of the 1990 DOE Tiger Team report states, ‘The overall 

assessment is that all levels of the GEND [General Electric Neutron Devices, 

another name for the Pinellas Plant] organization are receiving adequate 

radiological protection. This is primarily due to a GEND staff that appears willing 

to accept line responsibility for radiological safety along with a technically 

strong health physics staff providing direction.’”

11/20/2023 29
Observation 6: NIOSH Response

NIOSH concurs with this Observation.

11/20/2023 30
NIOSH Response to SC&A Observation 7

Bioassay sampling frequency requirements not followed as noted by 

Tiger Team
Observation 7: SC&A Key Points

“...the 1990 DOE Tiger Team report compliments the plant for maintaining low 

overall internal dose exposures but also makes an important finding on 

noncompliance issues related to the plant not following bioassay sampling 

frequency requirements.” 

11/20/2023 32
Observation 7: NIOSH Response

 NIOSH concurs with this Observation. 

 Response to Observation 5 details the bioassay compliance issue reported 

by the Tiger Team [DOE 1990] and evaluated in the SEC-00256 ER [NIOSH 

2021a].

11/20/2023 33
NIOSH Response to SC&A Observation 8

Contamination controls found generally good by Tiger Team
Observation 8: SC&A Key Points

“...the 1990 DOE Tiger Team report discusses the effectiveness of contamination 

controls at Pinellas and notes that while it is generally good, there are instances 

when it is not...”

11/20/2023 35
Observation 8: NIOSH Response

 Tiger Team assessment of ‘generally good’ seems to speak to the overall 

working conditions within the Pinellas Plant. 

 The negative Tiger Team examples relate to a transient condition. Transient 

conditions do not present a challenge to reconstructing internal dose for 

claimants (i.e., plant contamination control limits are low, minimizing 

potential dose). 

 The average internal dose for all monitored workers between 1986 and 1991 

ranged between 1.04 and 4.38 mrem/yr [Weaver 1992, PDF p. 11] and 

would include any exposure from plant-wide surface contamination.

11/20/2023 36
NIOSH Response to SC&A Observation 9

Bioassay sampling program implementation inadequacies noted by the 

Tiger Team
Observation 9: SC&A Key Point

“...the 1990 DOE Tiger Team report contains several radiological protection 

findings and concerns related to internal dosimetry that are relevant here. [...] 

NIOSH cited these Tiger Team findings as sufficient to qualify the SEC petition 

for further evaluation.”

11/20/2023 38
Observation 9: NIOSH Response

 NIOSH concurs with this Observation. 

 As noted by SC&A, the cited Tiger Team finding was the basis for the 

qualification of the Pinellas SEC Petition [NIOSH 2020]. 

 Response to Observation 5 details the bioassay compliance issue reported 

by the Tiger Team [DOE 1990] and evaluated in the SEC-00256 ER [NIOSH 

2021a].

11/20/2023 39
NIOSH Response to SC&A Observation 10

Tiger Team assessment of deficiency root causes: emphasis on 

production and mindset that Pinellas poses no unusual radiological risks
Observation 10: SC&A Key Point

“...probable root causes of some of [the Tiger Team’s] deficiency findings: 

 emphasis on production has traditionally overshadowed interest in fully 

complying with environment, safety and health requirements; 

 mindset that the Plant poses no unusual or unique risks.”

11/20/2023 41
Observation 10: NIOSH Response

 The cited issues relate to Management Assessment findings. These are not 

Pinellas Radiation Protection Program issues. 

 There is no implied deficiency in the ability to accurately monitor personnel 

radiation exposure or determine potential dose.

11/20/2023 42
NIOSH Response to SC&A Observation 11

Transition Year of 1990 after Tiger Team assessment led to overall 

reduced exposures
Observation 11: SC&A Key Points

“While data indicate a significant decrease for external doses from 1990 to 

1991, there was an increase in internal doses from tritium from 1990 to 1991, 

then a gradual decreasing trend during the years 1992–1995. The number of 

workers bioassayed for tritium remained reasonably consistent during the 

period 1986–1995, and the number of workers monitored for external exposure 

gradually decreased during the period 1985–1995. [...] To date, SC&A has not 

found indications that there are issues with exposure records that would 

prevent DR feasibility for the SEC period 1957–1990, nor for the period 1991–

1997.”

11/20/2023 44
Observation 11: NIOSH Response

NIOSH concurs with this Observation.

11/20/2023 45
NIOSH Response to SC&A Observation 12

ER is consistent with interview records
Observation 12: SC&A Key Point

“SC&A reviewed all available documented communication (i.e., interview) 

records. The interviews reflect the full date range of work at Pinellas and 

encompass a broad range of professions. From the interviews, it is clear that 

site employees had a different experience with the health and safety policies at 

the site based on their role and job function. In general, the interviewed 

workers in physics, engineering, chemistry, and lab-related professions had 

experience with the site internal and external monitoring program. The 

recollections reported in the interviews, in general, are consistent with the 

NIOSH SEC evaluation report.”

11/20/2023 47
Observation 12: NIOSH Response

NIOSH concurs with this Observation.

11/20/2023 48
NIOSH Response to SC&A Observation 13

Pinellas plant diligent in following up on contamination-related incidents 

and personnel exposures
Observation 13: SC&A Key Points

“...Pinellas Plant was diligent about following up on contamination-related 

incidents and personnel exposures. The reports show investigations into the 

causes of various incidents, and most (1) indicate that follow up monitoring was 

performed for employees involved in the incidents and (2) provide 

recommendations to prevent the incidents from reoccurring.”

“... given the lack of bioassay records for the years 1988–1990 ... it is possible 

that the program may not have captured all the internal exposures related to 

contamination incidents.”

11/20/2023 50
Observation 13: NIOSH Response

 Bioassay data is not missing (Observation 4).

 NIOSH has addressed the issue with bioassay compliance (Observations 5, 7, 

and 9), and there is no impact to feasibility to reconstruct internal dose.

11/20/2023 51
Conclusion
NIOSH Conclusion

NIOSH concludes that it is feasible to estimate the radiation dose that the 

evaluated class of Pinellas workers received. None of the observations in the 

SC&A Interim Review contradict the conclusions presented in the SEC-00256 ER.

11/20/2023 53
References (1 of 3)

Bioassays and Recounts 1989 Pinellas [1989]. Pinellas Plant, Largo, FL. January 3 through December 29. [SRDB Ref ID 197484]

DOE [1990]. Tiger Team assessment of the Pinellas Plant. Washington, DC: U.S. Department of Energy, Assistant Secretary for 

Environment, Safety and Health. DOE/EH-0126, May. [SRDB Ref ID: 46090]

DOE [1991]. Pinellas plant environmental monitoring report 1990. Pinellas Plant, Largo, FL: Department of Energy, Environmental 

Health and Safety Programs. NDPP-OSP-0053, August 9. [SRDB Ref ID: 12007]

GE [1989]. Pinellas plant environmental monitoring report 1988. Pinellas Plant, Largo, FL: General Electric Neutron Devices. GEPP-EV1193, June 1. [SRDB Ref ID: 13252]

GE [1990]. Pinellas plant environmental monitoring report 1989. Pinellas Plant, Largo, FL: General Electric Neutron Devices. GEPP-EV1061, June. [SRDB Ref ID: 13257]

NIOSH [2016a]. U.S. Department of Health and Human Services Centers for Disease Control National Institute for Occupational Safety 

and Health Advisory Board on Radiation and Worker Health Pinellas Plant Work Group Thursday, February 11, 2016. Transcript. 

Washington, DC: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for 

Occupational Safety and Health, Advisory Board on Radiation and Worker Health. [SRDB Ref ID: 187124]

11/20/2023 54
References (2 of 3)

NIOSH [2016b]. United States of America Centers for Disease Control National Institute for Occupational Safety and Health Advisory 

Board on Radiation and Worker Health 112th meeting Tuesday August 9, 2016. Transcript. Washington, DC: Department of Health 

and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, Advisory 

Board on Radiation and Worker Health. [SRDB Ref ID: 198486]

NIOSH [2021a]. Special exposure cohort petition evaluation report petition SEC-00256 rev. 0 Pinellas Plant qualified October 20,

2020. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute 

for Occupational Safety and Health. October 13. [SRDB Ref ID: 190456]

NIOSH [2021b]. U.S. Department of Health and Human Services Centers for Disease Control National Institute for Occupational Safety 

and Health Advisory Board on Radiation and Worker Health 143rd Meeting Wednesday, December 8, 2021. Transcript. Washington 

DC: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational 

Safety and Health, Advisory Board on Radiation and Worker Health. December 8. [SRDB Ref ID: 198487]

ORAUT [2016]. Pinellas Plant – occupational internal dose. Oak Ridge, TN: Oak Ridge Associated Universities Team. ORAUT-TKBS0029-5 Rev. 03, July 18. [SRDB Ref ID: 158070]

ORAUT [2017]. Pinellas Plant - occupational external dose. Oak Ridge, TN: Oak Ridge Associated Universities Team. ORAUT-TKBS0029-6 Rev. 02, December 11. [SRDB Ref ID: 168436]

11/20/2023 55
References (3 of 3)

ORAUT [2020]. Calculation of dose from intakes of special tritium compounds. Oak Ridge, TN: Oak Ridge Associated Universities

Team. ORAUT-OTIB-0066 Rev. 01, October 15. [SRDB Ref ID: 183483]

ORAUT [2023]. Pinellas bioassay data compiled to respond to SC&A observation 4 on the Pinellas ER 2023 ORAU team project 

spreadsheets. Oak Ridge, TN: Oak Ridge Associated Universities Team. August 11. [SRDB Ref ID: 197977]

Personnel bioassay results 1990 [1990]. Pinellas Plant: Largo, FL. January 2 through December 7. [SRDB Ref ID: 133535]

SC&A [2023]. Interim SC&A review of the SEC petition evaluation report for petition SEC-00256: Pinellas Plant 2023 - draft. Arlington, 

VA: SC&A. SCA-TR-2023-SEC001 Rev. 0, June 16. [SRDB Ref ID: 198062]

Tritium Bioassay Results 1988 [1988]. Pinellas Plant: Largo, FL. January 4 through December 27. [SRDB Ref ID: 133433]

Weaver AS [1992]. ALARA program report for CY1991. Pinellas Plant, Largo, FL: General Electric Neutron Devices. April 13. [SRDB Ref 

ID: 182933]

11/20/2023 56
For more information, contact CDC

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TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.